Development of Aceclofenac Mouth Dissolving Tablets using Solid Dispersion Technique: In-vitro Evaluation

Abstract:

Formulating mouth dissolving tablet using solid dispersion of drug shall not only improve solubility and consequent bioavailability but also improved patient compliance and convenience. The aim of the present study was to improve the solubility of Aceclofenac (ACE) by solid dispersion (SD) technique and formulate it as mouth dissolving tablets using some superdisintegrants. Solid dispersion (SD) of ACE was prepared by solvent evaporation method using PEG 6000 as carrier. Different weight ratios of drug and carrier i.e. 1:1, 1:2, 1:3, 1:4, and 1:5 were taken. Solubility of drug was determined in physical mixture and SD formulations. The prepared SD formulations were characterized by Fourier Transform Infra-Red (FTIR) spectroscopy, differential scanning calorimetry (DSC), and in vitro drug release. Mouth dissolving tablets of ACE were formulated using optimized SD formulation of drug and carrier along with super-disintegrants such as croscarmellose sodium, crospovidone, and sodium starch glycolate. From IR and DSC studies, it was concluded that there is change in crystalline form of drug into amorphous state during formation of SD. Mouth dissolving tablets containing crospovidone (20%) as super-disintegrants showed the fastest disintegration (39s) and in vitro drug release (92.2%). It can be concluded that combination of solid dispersion and super-disintegrants is a promising approach to prepare efficient mouth dissolving tablets of Aceclofenac.

Keywords: Mouth dissolving tablets; solid dispersion; aceclofenac; polyethylene glycol 6000